Guam § 40115 - Misbranded Drugs.

§ 40115. Misbranded Drugs.

A drug or device shall be deemed to be misbranded:

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(1) If its labeling is false or misleading in any particular, or if its

labeling or packaging fails to conform with the requirements of '40120 of

this Act;

(2) If in package form unless it bears a label containing (i) the name

and place of business of the manufacturer, packer or distributor; and (ii) an

accurate statement of the quantity of the contents in terms of weight,

measure or numerical count, which statement shall be separately and

accurately stated in a uniform location upon the principal display panel of

the label, except as exempted with respect to this clause by '40102(i)(3) of

this Act; provided, that under clause (ii) of this Paragraph reasonable

variations shall be permitted, and exemptions as to small packages shall be

allowed in accordance with regulations prescribed by the Consumer

Counsel or issued under the Federal Act;

(3) If any word, statement or other information required by or under

authority of this Act to appear on the label or labeling is not prominently

placed thereon with such conspicuousness (as compared with other words,

statements, designs or devices in the labeling) and in such terms as to render

it likely to be read and understood by the ordinary individual under

customary conditions of purchase and use;

(4) If it is for use by man and contains any quantity of the narcotic or

hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bramble,

cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana,

morphine, opium, paraldehyde, peyote or sulfonmethane, or any chemical

derivative of such substance, which derivative after investigation has been

found to be and designated as habit forming, by regulations issued by the

Director under this Act, or by regulations issued pursuant to '502(d) of the

Federal Act, unless its label bears the name and quantity or proportion of

such substance or derivative and in juxtaposition therewith the statement

Warning - May be habit forming;

(5) If it is a drug, unless:

(A) its label bears, to the exclusion of any other non-proprietary

name (except the applicable systematic chemical name or the chemical

formula), (i) the established name as defined in Paragraph (6) of the

drug, if such there be; and (ii) in case it is fabricated from two or more

ingredients, the established name and quantity of each active

ingredient, including the kind and quantity or proportion of any

alcohol and also including, whether active or not, the established name

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and quantity or proportion of any bromides, ether, chloroform,

acetanilid, acetphenetidin, aminopyrine, antipyrine, atropine, hyoscine,

hyoscyamine, arsenic, digitalis, digitalis glucoside, mercury, ouabain,

strophanthin, strychnine, thyroid or any derivative or preparation of

any such substances, contained therein; provided, that the requirement

for stating the quantity of the active ingredients, other than the

quantity of those specifically named in this Paragraph, shall apply only

to prescription drugs; and

(B) for any prescription drug the established name of such drug or

ingredient as the case may be, on such label (and on any labeling on

which a name for such drug or ingredient is used) is printed

prominently and in type at least half as large as that used thereon for

any proprietary name or designation for such drug or ingredient; and

provided that to the extent that compliance with the requirements of

clause (A)(ii) or clause (B) of this Subparagraph is impracticable,

exemptions shall be allowed under regulations promulgated by the

Director, or under the Federal Act;

(6) As used in this Paragraph and Paragraph (5), the term "established

name," with respect to a drug or ingredient thereof, means:

(A) the applicable official name designated pursuant to '508 of

the Federal Act, or

(B) if there is no such name and such drug, or such ingredient, is

an article recognized in an official compendium, then official title

thereof in such compendium, or

(C) if neither clause (A) nor Clause (B) of this Subparagraph

applies, then the common or usual name, if any, of such drug or of

such ingredient; provided further, that where clause (B) of this

Subparagraph applies to an article recognized in the United States

Pharmacopoeia and in the Homeopathic Pharmacopoeia under

different official titles, the official title used in the United States

Pharmacopoeia shall apply unless it is labeled and offered for sale as a

homeopathic drug, in which case the official title used in the

Homeopathic Pharmacopoeia shall apply;

(7) Unless its labeling bears (i) adequate directions for use, and (ii)

such adequate warnings against use in those pathological conditions or by

children where its use may be dangerous to health, or against unsafe dosage

or methods or duration of administration or application, in such manner and

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form, as are necessary for the protection of users; provided, that where any

requirement of clause (i) of this Paragraph, as applied to any drug or device,

is not necessary for the protection of the public health, the Director shall

promulgate regulations exempting such drug or device from such

requirements; provided further, that articles exempted under regulations

issued under '502(f) of the Federal Act may also be exempt;

(8) If it purports to be a drug the name of which is recognized in an

official compendium, unless it is packaged and labeled as prescribed

therein; provided, that the method of packing may be modified with the

consent of the Director or if consent is obtained under the Federal Act.

Whenever a drug is recognized in both the United States Pharmacopoeia

and the Homeopathic Pharmacopoeia of the United States, it shall be subject

to the requirements of the United States Pharmacopoeia with respect to

packaging and labeling unless it is labeled and offered for sale as a

homeopathic drug, in which case it shall be subject to the provisions of the

Homeopathic Pharmacopoeia of the United States and not to those of the

United States Pharmacopoeia; provided further, that in the event of

inconsistency between the requirements of this Paragraph and those of

Paragraph (5) as to the name by which the drug or its ingredients shall be

designated, the requirements of Paragraph (e) shall prevail;

(9) If it has been found by the Director or under the Federal Act to be a

drug liable to deterioration, unless it is packaged in such form and manner,

and its label bears a statement of such precautions, as the regulations issued

by the Director or under the Federal Act require as necessary for the

protection of public health;

(10) If it is a drug and its container is so made, formed or filled as to be

misleading (i) if it is an imitation of another drug; (ii) if it is offered for sale

under the name of another drug;

(11) If it is dangerous to health when used in the dosage, or with the

frequency or duration prescribed, recommended or suggested in the labeling

thereof;

(12) If it is, or purports to be, or is represented as a drug composed

wholly or partly of insulin, unless (i) it is from a batch with respect to which

a certificate or release has been issued pursuant to '506 of the Federal Act,

and (ii) such certificate or release is in effect with respect to such drug;

(13) If it is, or purports to be, or is represented as a drug composed

wholly or partly of any kind of penicillin, streptomycin, chlortetracycline,

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chloramphenicol, bacitracin or any other antibiotic drug, or any derivative

thereof, unless (i) it is from a batch with respect to which a certificate or

release has been issued pursuant to '507 of the Federal Act, and (ii) such

certificate or release is in effect with respect to such drug; provided, that

this Paragraph shall not apply to any drug or class of drugs exempted by

regulations promulgated under '507(c) or (d) of the Federal Act. For the

purpose of this Paragraph the term "antibiotic drug" means any drug

intended for use by man containing any quantity of any chemical substance

which is produced by microorganisms and which has the capacity to inhibit

or destroy microorganisms in dilute solution (including, the chemically

synthesized equivalent of any such substance);

(14) If it is a color additive, the intended use of which in or on drugs is

for the purpose of coloring only, unless its packaging and labeling are in

conformity with such packaging and labeling requirements applicable to

such color additive, prescribed under the provisions of '40113 or of the

Federal Act;

(15) In the case of any prescription drug distributed or offered for sale

in this Territory unless the manufacturer, packer or distributor thereof

includes in all advertisements and other descriptive printed matter issued or

caused to be issued by the manufacturer, packer or distributor with respect

to that drug a true statement of (i) the established name, as defined in

Section 16(c)(2) of this Act, printed prominently and in type at least half as

large as that used for any trade or brand name thereof, (ii) the formula

showing quantitatively each ingredient of such drug to the extent required

for labels under '502(c) of the Federal Act, and (iii) such other information

in brief summary relating to side effects, contraindications and effectiveness

as shall be required in regulations issued under the Federal Act;

(16) If a trademark, trade name or other identifying mark, imprint or

device of another or any likeness of the foregoing has been placed thereon

or upon its container with intent to defraud; or

(17) Drugs and devices which are in accordance with the practice of

the trade, to be processed, labeled or repacked in substantial quantities at

establishments other than those where originally processed or packed shall

be exempt from any labeling or packaging requirements of this Act;

provided, that such drugs and devices are being delivered, manufactured,

processed, labeled, repacked or otherwise held in compliance with regula-

tions issued by the Director or under the Federal Act.